Drug product

ADVANCE HAND SANITIZER, (ethyl alcohol 70%), 16 FL OZ (473.2 mL), Imported by: Dibar Labs, LLC,.Sugar Land, TX 77479, Distributed by: Lifetime Health Services, Pharr, TX 78577, Made in Mexico, NDC; 79284-005-00. UPC 8 60004 06470 1

D-0647-2021

May 11, 2021

Class II

Product summary

Firm: DIBAR NUTRICIONAL S DE RL DE CV
Event: Event 87917
Status: Terminated
Classification: Class II
Quantity: Unknown quantity
Official record key: drug-enforcement:D-0647-2021

Official wording

Reason: CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.

Code information: All lots

Distribution pattern: Distributed Nationwide in the USA

Derived failure modes

Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0

found to contain methanol
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations